Atrial FibrillationGARFIELD-AFNCT01090362
Global Anticoagulant Registry in the Field
An observational study of Atrial Fibrillation, run by Thrombosis Research Institute at 35 sites in 35 countries.
Trial summary
The Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF Registry) is a non-interventional, observational study that characterized a global population of non-valvular atrial fibrillation patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 57,250 participants
- Where
- 35 sitesin 35 countries
- Study dates
- 21 Dec 2009to 18 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female patients newly diagnosed with atrial fibrillation (AF) who are with at least one additional risk of stroke from 18 countries globally.
Who may be able to join
- Prospective Cohort
- Written informed consent
- Age 18 years and older
- New diagnosis of non-valvular atrial fibrillation (diagnosed within the last 6 weeks) with at least one additional risk factor for stroke and regardless of therapy.
- Retrospective validation cohort
- Written informed consent
- Age 18 years and older
- Diagnosis of non-valvular AF (diagnosed 6-24 months prior to enrolment) with at least one additional risk factor for stroke and regardless of therapy.
Who cannot join
- No further follow-up envisaged or possible within enrolling hospital or with associated family practitioner.
- Patients with transient AF secondary to a reversible cause.
- Patients recruited in controlled clinical trials.
Trial locations and contacts
35 sites in 35 countries.
35 sites in 35 countries
Argentina1 site
Dr Hector Luciardi, National Co-ordinating Investigator, National University of Tucuman
San Miguel de Tucumán
Australia1 site
Harry Gibbs, National Co-ordinating Investigator, The Alfred Hospital
Melbourne
Austria1 site
Marianne Brodmann: National Co-ordinating Investigator, Medizinische Universität Graz
Graz
Belgium1 site
Dr Frank Cools, National Co-ordinating Investigator, AZ Klina
Brasschaat
Brazil1 site
Dr Antonio Barretto, National Coordinating Investigator, Hospital Santa Marcelina,
São Paulo
Canada1 site
Prof Stuart Connolly and Dr John Eikelboom, National Coodinating Investigators, Mc Master University
Hamilton
Chile1 site
Dr Ramon Corbalan, National Coordinating Investigator, Pontifica Universidad Catolica de Chile
Santiago
China1 site
Prof Zin-Cheng, National Coordinating Investigator, Peking Union Medical College & Chinese Academy Medical Sciences People Hospital
Beijing
Czechia1 site
Dr Petr Jansky, National Coordinating Investigator, Cardiovaskular Center, Motol Univesity Hospital
Prague
Denmark1 site
Prof Joern Dalsgaard Nielsen, National Coordinating Investigator, Bispebjerg & Frederiksberg Hospitals
Frederiksberg
Egypt1 site
Dr. Hany Ragy, National Coordinating Investigator, Hayat Hospital
Cairo
Finland1 site
Prof Pekka Raatikainen, National Coordinating Investigator, Univesrsity of Tampere
Tampere
France1 site
Prof. Jean-Yues LeHeuzey, National Coordinating Investigator, Hopital Europeen Georges Pompidou
Paris
Germany1 site
Prof Harald Darius, National oordinating Investigator, Vivantes Klinikum Neukölln
Berlin
Hungary1 site
Dr Matyas Keltai, National Coordinating Investigator, Hungarian Institute of Cardiology
Budapest
India1 site
Dr Sawney, National Coordinating Investigator, Sir Ganga Ram Hospital, New Delhi
Bangalore
Italy1 site
Profs Giancarlo Agnelli and Giuseppe Ambrosio, National Coordinating Investigators, University of Perugia
Perugia
Japan1 site
Professor Yukihiro Koretsune, National Coordinating Investigator, Osaka National Hospital
Osaka
Mexico1 site
Dr Carlos Jerjes Sanchez Diaz, National Coordinating Investigator,Tecnologico de Monterrey
Monterrey
Netherlands1 site
Professor Hugo ten Cate, National Coordinating Investigator, Cardiovascular Research Institute Maastricht
Maastricht
Norway1 site
Professor Dan Atar, National Coordinating Investigator, Oslo University Hospital
Oslo
Poland1 site
Prof Janina Stępińska, National Coordinating Investigator, Institute of Cardiology, Warsaw
Warsaw
Russia1 site
Professor Elizaveta Panchenko, National Coordinating Investigator, Cardiology Research and Production Center
Moscow
Singapore1 site
Dr Toon Wei Lim, National Coordinating Investigator, National University Hospital
Singapore
South Africa1 site
Prof. Barry Jacobson, National Coordinating Investigator, University of the Witwatersrand
Johannesburg
South Korea1 site
Prof. Seil Oh, National Coordinating Investigator, National University Hospital
Seoul
Spain1 site
Dr Xavier Vinolas, National Coordinating Investigator, Hospital Santa Creu y San Pau
Barcelona
Sweden1 site
Dr Marten Rosenqvist, National Coordinating Investigator, Karolinska Institute
Stockholm
Switzerland1 site
Dr Jan Steffel, National Coordinating Investigator, University Hospital
Zurich
Thailand1 site
Prof. Pantep Angchaisuksiri, National Coordinating Investigator, Ramathibodi Hospital, Mahidol University
Bangkok
Turkey (Türkiye)1 site
Professor Ali Oto, National Coordinating Investigator, Memorial Ankara Hospital
Ankara
Ukraine1 site
Prof. Alexandr Parkhomenko, National Coordinating Investigator, Strazhesko Institute of Cardiology
Kiev
United Arab Emirates1 site
Prof. Wael Al Mahmeed, National Coordinating Investigator, SKMC Cardiac Siences
Abu Dhabi
United Kingdom1 site
Prof. David Fitzmaurice, National Coordinating Investigator, University of Warwick
Coventry
About this study
Official title: Prospective, Multi Centre, International Registry of Male and Female Patients Newly Diagnosed With Atrial Fibrillation.
The Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF Registry) is a non-interventional, observational study that characterized a global population of non-valvular atrial fibrillation patients. The registry was used to document global baseline characteristics, current treatment strategies and outcome measures. Characterisation of a number of AF sub-populations was also completed. GARFIELD-AF is an independent academic research initiative sponsored by the Thrombosis Research Institute (London, UK) and supported by an unrestricted research grant from Bayer AG (Berlin, Germany).
Read the detailed description
Using data from more than 1000 randomly selected centres across 35 countries, representing all possible care settings, the registry will help to characterize real-life anticoagulant treatment patterns and outcomes, including rates of stroke and bleeding complications, as well as provide data on other important issues, such as physicians' compliance with guidelines and patients' adherence to therapy. This is particularly timely as standard practice moves away from vitamin K antagonist (VKA)-dominated therapy and towards a new era of novel oral anticoagulants (OACs), i.e. direct Factor Xa inhibitors and direct thrombin inhibitors.
To ensure a dataset that truly reflects current practice, the investigators are requested to prospectively enrol all newly diagnosed patients with non-valvular AF who have at least one additional investigator-determined risk factor for stroke. Patients are consecutively recruited into one of five cohorts and followed up for at least 2 years.
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Anticoagulation, Stroke, Stroke prevention, Health Economics
- Medical subject headings
- Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Cohort complete with 5,088 retrospective patients and 5,499 prospective patients recruited from 19 countries. | |
| Cohort 2 | Cohort completed with 11,351 patients enrolled from 30 countries | |
| Cohort 3 | Cohort 3 completed with 11,139 patients enrolled globally from 32 countries | |
| Cohort 4 | Cohort 4 completed with 11,2780 patients enrolled from 35 countries. | |
| Cohort 5 | Final cohort completed with 12,186 patients enrolled. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
All cause mortality including cardiovascular and non-cardiovascular death
Measured: 4 months
Death
All cause mortality including cardiovascular and non-cardiovascular death
Measured: 8 months
Death
All cause mortality including cardiovascular and non-cardiovascular death
Measured: 12 months
Death
All cause mortality including cardiovascular and non-cardiovascular death
Measured: 16 months
Death
All cause mortality including cardiovascular and non-cardiovascular death
Measured: 20 months
Death
All cause mortality including cardiovascular and non-cardiovascular death
Measured: 24 months
Death
All cause mortality including cardiovascular and non-cardiovascular death
Measured: 3 years
Death
All cause mortality including cardiovascular and non-cardiovascular death
Measured: 4 years
Stroke/Systemic embolism (SE)
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
Measured: 4 months
Stroke/Systemic embolism (SE)
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
Measured: 8 months
Stroke/Systemic embolism (SE)
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
Measured: 12 months
Stroke/Systemic embolism (SE)
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
Measured: 16 months
Stroke/Systemic embolism (SE)
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
Measured: 20 months
Stroke/Systemic embolism (SE)
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
Measured: 24 months
Stroke/Systemic embolism (SE)
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
Measured: 3 years
Stroke/Systemic embolism (SE)
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
Measured: 4 years
Major bleeding
Defined as clinically overt bleeding associated with a critical site or hemorrhagic stroke, a fall in haemoglobin of ≥2 g/dl, transfusion of ≥2 units of packed red blood cells, or fatal outcome.
Measured: 4 months
Major bleeding
Defined as clinically overt bleeding associated with a critical site or hemorrhagic stroke, a fall in haemoglobin of ≥2 g/dl, transfusion of ≥2 units of packed red blood cells, or fatal outcome.
Measured: 8 months
Major bleeding
Defined as clinically overt bleeding associated with a critical site or hemorrhagic stroke, a fall in haemoglobin of ≥2 g/dl, transfusion of ≥2 units of packed red blood cells, or fatal outcome.
Measured: 12 months
Major bleeding
Defined as clinically overt bleeding associated with a critical site or hemorrhagic stroke, a fall in haemoglobin of ≥2 g/dl, transfusion of ≥2 units of packed red blood cells, or fatal outcome.
Measured: 16 months
Major bleeding
Defined as clinically overt bleeding associated with a critical site or hemorrhagic stroke, a fall in haemoglobin of ≥2 g/dl, transfusion of ≥2 units of packed red blood cells, or fatal outcome.
Measured: 20 months
Major bleeding
Defined as clinically overt bleeding associated with a critical site or hemorrhagic stroke, a fall in haemoglobin of ≥2 g/dl, transfusion of ≥2 units of packed red blood cells, or fatal outcome.
Measured: 24 months
Major bleeding
Defined as clinically overt bleeding associated with a critical site or hemorrhagic stroke, a fall in haemoglobin of ≥2 g/dl, transfusion of ≥2 units of packed red blood cells, or fatal outcome.
Measured: 3 years
Major bleeding
Defined as clinically overt bleeding associated with a critical site or hemorrhagic stroke, a fall in haemoglobin of ≥2 g/dl, transfusion of ≥2 units of packed red blood cells, or fatal outcome.
Measured: 4 years
Secondary outcomes (56)
Cerebrovascular events defined as Stroke
Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
Measured: 4 months
Cerebrovascular events defined as Stroke
Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
Measured: 8 months
Cerebrovascular events defined as Stroke
Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
Measured: 12 months
Cerebrovascular events defined as Stroke
Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
Measured: 16 months
Cerebrovascular events defined as Stroke
Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
Measured: 20 months
Cerebrovascular events defined as Stroke
Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
Measured: 24 months
Cerebrovascular events defined as Stroke
Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
Measured: 3 years
Cerebrovascular events defined as Stroke
Primary ischaemic stroke, Primary intracerebral haemorrhage, Secondary haemorrhagic ischaemic stroke.
Measured: 4 years
Transient Ischemic Attacks (TIA)
Number of Transient Ischemic Attacks (TIA)
Measured: 4 months
Transient Ischemic Attacks (TIA)
Number of Transient Ischemic Attacks (TIA)
Measured: 8 months
Transient Ischemic Attacks (TIA)
Number of Transient Ischemic Attacks (TIA)
Measured: 12 months
Transient Ischemic Attacks (TIA)
Number of Transient Ischemic Attacks (TIA)
Measured: 16 months
Transient Ischemic Attacks (TIA)
Number of Transient Ischemic Attacks (TIA)
Measured: 20 months
Transient Ischemic Attacks (TIA)
Number of Transient Ischemic Attacks (TIA)
Measured: 24 months
Transient Ischemic Attacks (TIA)
Number of Transient Ischemic Attacks (TIA)
Measured: 3 years
Transient Ischemic Attacks (TIA)
Number of Transient Ischemic Attacks (TIA)
Measured: 4 years
Acute coronary syndromes
Number including unstable angina, STEMI, Non-STEMI
Measured: 4 months
Acute coronary syndromes
Number including unstable angina, STEMI, Non-STEMI
Measured: 8 months
Acute coronary syndromes
Number Including unstable angina, STEMI, Non-STEMI
Measured: 12 months
Acute coronary syndromes
Number including unstable angina, STEMI, Non-STEMI
Measured: 16 months
Acute coronary syndromes
Number including unstable angina, STEMI, Non-STEMI
Measured: 20 months
Acute coronary syndromes
Number including Unstable angina, STEMI, Non-STEMI
Measured: 24 months
Acute coronary syndromes
Number including unstable angina, STEMI, Non-STEMI
Measured: 3 years
Acute coronary syndromes
Number including unstable angina, STEMI, Non-STEMI
Measured: 4 years
Therapy persistence
Participant duration of time on therapy
Measured: 4 months
Therapy persistence
Participant duration of time on therapy
Measured: 8 months
Therapy persistence
Participant duration of time on therapy
Measured: 12 months
Therapy persistence
Participant duration of time on therapy
Measured: 16 months
Therapy persistence
Participant duration of time on therapy
Measured: 20 months
Therapy persistence
Participant duration of time on therapy
Measured: 24 months
Therapy persistence
Participant rate of discontinuation
Measured: 3 years
Therapy persistence
Participant duration of time on therapy
Measured: 4 years
Incidences of other clinical events
Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
Measured: 4 months
Incidences of other clinical events
Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
Measured: 8 months
Incidences of other clinical events
Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
Measured: 12 months
Incidences of other clinical events
Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
Measured: 16 months
Incidences of other clinical events
Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
Measured: 20 months
Incidences of other clinical events
Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
Measured: 24 months
Incidences of other clinical events
Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
Measured: 3 years
Incidences of other clinical events
Myocardial infarction (MI)/ acute coronary syndromes (ACS), and congestive heart failure (CHF)
Measured: 4 years
Bleeding Events
Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
Measured: 4 months
Bleeding Events
Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
Measured: 8 months
Bleeding Events
Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
Measured: 12 months
Bleeding Events
Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
Measured: 16 months
Bleeding Events
Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
Measured: 20 months
Bleeding Events
Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
Measured: 24 months
Bleeding Events
Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
Measured: 3 years
Bleeding Events
Frequency, severity, location, outcome, Healthcare utilisation used for bleeding event
Measured: 4 years
Pulmonary Embolism
Number of participants with a Pulmonary Embolism
Measured: 4 months
Pulmonary Embolism
Number of participants with a Pulmonary Embolism
Measured: 8 months
Pulmonary Embolism
Number of participants with a Pulmonary Embolism
Measured: 12 months
Pulmonary Embolism
Number of participants with a Pulmonary Embolism
Measured: 16 months
Pulmonary Embolism
Number of participants with a Pulmonary Embolism
Measured: 20 months
Pulmonary Embolism
Number of participants with a Pulmonary Embolism
Measured: 24 months
Pulmonary Embolism
Number of participants with a Pulmonary Embolism
Measured: 3 years
Pulmonary Embolism
Number of participants with a Pulmonary Embolism
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2010 (estimated)
- Study start21 Dec 2009
- Primary completion16 Jun 2019
- Study completion18 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (43)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57,250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thrombosis Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer, University of Birmingham, Brigham and Women's Hospital, Quintiles, Inc., Advanced Drug and Device Services SAS, Apothecaries Clinical Research
- Responsible party
- Sponsor
- Investigators
- Ajay K Kakkar, Study director, Thrombosis Research Institute, London, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01090362
- Sponsor's protocol ID
- TRI08888
- Acronym
- GARFIELD-AF
- Status last verified
- Apr 2021
- First submitted
- 18 Mar 2010
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kakkar AK, Mueller I, Bassand JP, Fitzmaurice DA, Goldhaber SZ, Goto S, Haas S, Hacke W, Lip GY, Mantovani LG, Verheugt FW, Jamal W, Misselwitz F, Rushton-Smith S, Turpie AG. International longitudinal registry of patients with atrial fibrillation at risk of stroke: Global Anticoagulant Registry in the FIELD (GARFIELD). Am Heart J. 2012 Jan;163(1):13-19.e1. doi: 10.1016/j.ahj.2011.09.011. Epub 2011 Nov 20.
PubMed 22172431Apenteng PN, Murray ET, Holder R, Hobbs FD, Fitzmaurice DA; UK GARFIELD Investigators and GARFIELD Steering Committee. An international longitudinal registry of patients with atrial fibrillation at risk of stroke (GARFIELD): the UK protocol. BMC Cardiovasc Disord. 2013 Apr 23;13:31. doi: 10.1186/1471-2261-13-31.
PubMed 23617744Aalbers J. GARFIELD: a window on the real-life treatment of atrial fibrillation - South Africa joins the GARFIELD registry. Cardiovasc J Afr. 2012 Oct;23(9):528. No abstract available.
PubMed 23108524Kakkar AK, Mueller I, Bassand JP, Fitzmaurice DA, Goldhaber SZ, Goto S, Haas S, Hacke W, Lip GY, Mantovani LG, Turpie AG, van Eickels M, Misselwitz F, Rushton-Smith S, Kayani G, Wilkinson P, Verheugt FW; GARFIELD Registry Investigators. Risk profiles and antithrombotic treatment of patients newly diagnosed with atrial fibrillation at risk of stroke: perspectives from the international, observational, prospective GARFIELD registry. PLoS One. 2013 May 21;8(5):e63479. doi: 10.1371/journal.pone.0063479. Print 2013.
PubMed 23704912Cheng CY, Lian TY, Zhu XJ, Virdone S, Sun K, Camm J, Li XM, Goto S, Pieper K, Kayani G, Fang XH, Jing ZC, Kakkar AK; GARFIELD-AF Investigators. Atrial fibrillation outcomes in patients from Asia and non-Asia countries: insights from GARFIELD-AF. Open Heart. 2025 Feb 6;12(1):e003109. doi: 10.1136/openhrt-2024-003109.
PubMed 39914996Himmelreich JCL, Virdone S, Camm AJ, Pieper K, Harskamp RE, Verheugt FWA, Bassand JP, Misselwitz F, Pereira-Barretto AC, Cools F, Gibbs H, Kakkar AK; GARFIELD-AF investigators. Emulation of ARISTOTLE and ROCKET AF trials in real-world atrial fibrillation patients results in similar efficacy and safety as original landmark trials: insights from the GARFIELD-AF registry. Open Heart. 2025 Jan 19;12(1):e002966. doi: 10.1136/openhrt-2024-002966.
PubMed 39832940Camm CF, Virdone S, Jerjes-Sanchez C, Oh S, Eikelboom JW, Oto A, Fox KAA, Camm AJ, Pieper KS, Goto S, Ragy H, Kakkar AK; GARFIELD-AF registry. Association of care specialty with anticoagulant prescription and clinical outcomes in newly diagnosed atrial fibrillation: Results from the GARFIELD-AF registry. Int J Cardiol. 2025 Feb 15;421:132866. doi: 10.1016/j.ijcard.2024.132866. Epub 2024 Dec 2.
PubMed 39631531Bassand JP, Virdone S, Camm AJ, Fox KAA, Goldhaber SZ, Goto S, Haas S, Hacke W, Kayani G, Keltai M, Misselwitz F, Pieper KS, Turpie AGG, Verheugt FWA, Kakkar AK; GARFIELD-AF Investigators. Oral anticoagulation across diabetic subtypes in patients with newly diagnosed atrial fibrillation: A report from the GARFIELD-AF registry. Diabetes Obes Metab. 2023 Oct;25(10):3040-3053. doi: 10.1111/dom.15202. Epub 2023 Jul 12.
PubMed 37435777Camm AJ, Steffel J, Virdone S, Bassand JP, Fox KAA, Goldhaber SZ, Goto S, Haas S, Turpie AGG, Verheugt FWA, Misselwitz F, Herreros RC, Kayani G, Pieper KS, Kakkar AK; GARFIELD-AF Investigators. Guideline-directed medical therapies for comorbidities among patients with atrial fibrillation: results from GARFIELD-AF. Eur Heart J Open. 2023 May 19;3(3):oead051. doi: 10.1093/ehjopen/oead051. eCollection 2023 May.
PubMed 37293139Yuan L, Yang L, Zhang S, Xu Z, Qin J, Shi Y, Yu P, Wang Y, Bao Z, Xia Y, Sun J, He W, Chen T, Chen X, Hu C, Zhang Y, Dong C, Zhao P, Wang Y, Jiang N, Lv B, Xue Y, Jiao B, Gao H, Chai K, Li J, Wang H, Wang X, Guan X, Liu X, Zhao G, Zheng Z, Yan J, Yu H, Chen L, Ye Z, You H, Bao Y, Cheng X, Zhao P, Wang L, Zeng W, Tian Y, Chen M, You Y, Yuan G, Ruan H, Gao X, Xu J, Xu H, Du L, Zhang S, Fu H, Cheng X. Development of a tongue image-based machine learning tool for the diagnosis of gastric cancer: a prospective multicentre clinical cohort study. EClinicalMedicine. 2023 Feb 6;57:101834. doi: 10.1016/j.eclinm.2023.101834. eCollection 2023 Mar.
PubMed 36825238van Husen G, Virdone S, Pieper K, Kayani G, Fox KAA. Universal Clinician Device for improving risk prediction and management of patients with atrial fibrillation: an assumed benefit analysis. Eur Heart J Digit Health. 2022 Mar 25;3(2):181-194. doi: 10.1093/ehjdh/ztac011. eCollection 2022 Jun.
PubMed 36713019Fox KAA, Virdone S, Bassand JP, Camm AJ, Goto S, Goldhaber SZ, Haas S, Kayani G, Koretsune Y, Misselwitz F, Oh S, Piccini JP, Parkhomenko A, Sawhney JPS, Stepinska J, Turpie AGG, Verheugt FWA, Kakkar AK; GARFIELD-AF investigators*. Do baseline characteristics and treatments account for geographical disparities in the outcomes of patients with newly diagnosed atrial fibrillation? The prospective GARFIELD-AF registry. BMJ Open. 2022 Jan 7;12(1):e049933. doi: 10.1136/bmjopen-2021-049933.
PubMed 34996784Pope MK, Hall TS, Schirripa V, Radic P, Virdone S, Pieper KS, Le Heuzey JY, Jansky P, Fitzmaurice DA, Cappato R, Atar D, Camm AJ, Kakkar AK; GARFIELD-AF investigators. Cardioversion in patients with newly diagnosed non-valvular atrial fibrillation: observational study using prospectively collected registry data. BMJ. 2021 Oct 27;375:e066450. doi: 10.1136/bmj-2021-066450.
PubMed 34706884Cools F, Johnson D, Camm AJ, Bassand JP, Verheugt FWA, Yang S, Tsiatis A, Fitzmaurice DA, Goldhaber SZ, Kayani G, Goto S, Haas S, Misselwitz F, Turpie AGG, Fox KAA, Pieper KS, Kakkar AK; GARFIELD-AF Investigators. Risks associated with discontinuation of oral anticoagulation in newly diagnosed patients with atrial fibrillation: Results from the GARFIELD-AF Registry. J Thromb Haemost. 2021 Sep;19(9):2322-2334. doi: 10.1111/jth.15415. Epub 2021 Jul 23.
PubMed 34060704Fox KAA, Virdone S, Pieper KS, Bassand JP, Camm AJ, Fitzmaurice DA, Goldhaber SZ, Goto S, Haas S, Kayani G, Oto A, Misselwitz F, Piccini JP, Dalgaard F, Turpie AGG, Verheugt FWA, Kakkar AK; GARFIELD-AF Investigators. GARFIELD-AF risk score for mortality, stroke, and bleeding within 2 years in patients with atrial fibrillation. Eur Heart J Qual Care Clin Outcomes. 2022 Mar 2;8(2):214-227. doi: 10.1093/ehjqcco/qcab028.
PubMed 33892489
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi Centre, International Registry of Male and Female Patients Newly Diagnosed With Atrial Fibrillation.
- ClinicalTrials.gov ID
- NCT01090362
- Acronym / sponsor ID
- GARFIELD-AF / TRI08888
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Anticoagulation, Stroke, Stroke prevention, Health Economics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57,250 participants (actual)
- Lead sponsor
- Thrombosis Research InstituteUniversity, hospital or other
- Collaborators
- Bayer, University of Birmingham, Brigham and Women's Hospital, Quintiles, Inc., Advanced Drug and Device Services SAS, Apothecaries Clinical Research
- Study start
- 21 Dec 2009 (actual)
- Primary completion
- 16 Jun 2019 (actual)
- Study completion
- 18 May 2020 (actual)
- First posted
- 19 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF Registry) is a non-interventional, observational study that characterized a global population of non-valvular atrial fibrillation patients. The registry was used to document global baseline characteristics, current treatment strategies and outcome measures. Characterisation of a number of AF sub-populations was also completed. GARFIELD-AF is an independent academic research initiative sponsored by the Thrombosis Research Institute (London, UK) and supported by an unrestricted research grant from Bayer AG (Berlin, Germany).
Detailed description
Using data from more than 1000 randomly selected centres across 35 countries, representing all possible care settings, the registry will help to characterize real-life anticoagulant treatment patterns and outcomes, including rates of stroke and bleeding complications, as well as provide data on other important issues, such as physicians' compliance with guidelines and patients' adherence to therapy. This is particularly timely as standard practice moves away from vitamin K antagonist (VKA)-dominated therapy and towards a new era of novel oral anticoagulants (OACs), i.e. direct Factor Xa inhibitors and direct thrombin inhibitors.
To ensure a dataset that truly reflects current practice, the investigators are requested to prospectively enrol all newly diagnosed patients with non-valvular AF who have at least one additional investigator-determined risk factor for stroke. Patients are consecutively recruited into one of five cohorts and followed up for at least 2 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Cohort complete with 5,088 retrospective patients and 5,499 prospective patients recruited from 19 countries. |
| Cohort 2 | – | –Cohort completed with 11,351 patients enrolled from 30 countries |
| Cohort 3 | – | –Cohort 3 completed with 11,139 patients enrolled globally from 32 countries |
| Cohort 4 | – | –Cohort 4 completed with 11,2780 patients enrolled from 35 countries. |
| Cohort 5 | – | –Final cohort completed with 12,186 patients enrolled. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients newly diagnosed with atrial fibrillation (AF) who are with at least one additional risk of stroke from 18 countries globally.
Key inclusion criteria (8 listed)
- Prospective Cohort
- Written informed consent
- Age 18 years and older
- New diagnosis of non-valvular atrial fibrillation (diagnosed within the last 6 weeks) with at least one additional risk factor for stroke and regardless of therapy.
- Retrospective validation cohort
Key exclusion criteria (3 listed)
- No further follow-up envisaged or possible within enrolling hospital or with associated family practitioner.
- Patients with transient AF secondary to a reversible cause.
- Patients recruited in controlled clinical trials.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Death
Time frame: 4 months
All cause mortality including cardiovascular and non-cardiovascular death
Death
Time frame: 8 months
All cause mortality including cardiovascular and non-cardiovascular death
Death
Time frame: 12 months
All cause mortality including cardiovascular and non-cardiovascular death
Death
Time frame: 16 months
All cause mortality including cardiovascular and non-cardiovascular death
Death
Time frame: 20 months
All cause mortality including cardiovascular and non-cardiovascular death
Death
Time frame: 24 months
All cause mortality including cardiovascular and non-cardiovascular death
Death
Time frame: 3 years
All cause mortality including cardiovascular and non-cardiovascular death
Death
Time frame: 4 years
All cause mortality including cardiovascular and non-cardiovascular death
Stroke/Systemic embolism (SE)
Time frame: 4 months
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
Stroke/Systemic embolism (SE)
Time frame: 8 months
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
Stroke/Systemic embolism (SE)
Time frame: 12 months
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
Stroke/Systemic embolism (SE)
Time frame: 16 months
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
Stroke/Systemic embolism (SE)
Time frame: 20 months
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
Stroke/Systemic embolism (SE)
Time frame: 24 months
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
Stroke/Systemic embolism (SE)
Time frame: 3 years
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
Stroke/Systemic embolism (SE)
Time frame: 4 years
Stroke/SE was defined as the combined end points of ischemic stroke, and SE
Major bleeding
Time frame: 4 months
Defined as clinically overt bleeding associated with a critical site or hemorrhagic stroke, a fall in haemoglobin of ≥2 g/dl, transfusion of ≥2 units of packed red blood cells, or fatal outcome.
Major bleeding
Time frame: 8 months
Defined as clinically overt bleeding associated with a critical site or hemorrhagic stroke, a fall in haemoglobin of ≥2 g/dl, transfusion of ≥2 units of packed red blood cells, or fatal outcome.
Major bleeding
Time frame: 12 months
Defined as clinically overt bleeding associated with a critical site or hemorrhagic stroke, a fall in haemoglobin of ≥2 g/dl, transfusion of ≥2 units of packed red blood cells, or fatal outcome.
Major bleeding
Time frame: 16 months
Defined as clinically overt bleeding associated with a critical site or hemorrhagic stroke, a fall in haemoglobin of ≥2 g/dl, transfusion of ≥2 units of packed red blood cells, or fatal outcome.
Major bleeding
Time frame: 20 months
Defined as clinically overt bleeding associated with a critical site or hemorrhagic stroke, a fall in haemoglobin of ≥2 g/dl, transfusion of ≥2 units of packed red blood cells, or fatal outcome.
Major bleeding
Time frame: 24 months
Defined as clinically overt bleeding associated with a critical site or hemorrhagic stroke, a fall in haemoglobin of ≥2 g/dl, transfusion of ≥2 units of packed red blood cells, or fatal outcome.
Major bleeding
Time frame: 3 years
Defined as clinically overt bleeding associated with a critical site or hemorrhagic stroke, a fall in haemoglobin of ≥2 g/dl, transfusion of ≥2 units of packed red blood cells, or fatal outcome.
Major bleeding
Time frame: 4 years
Defined as clinically overt bleeding associated with a critical site or hemorrhagic stroke, a fall in haemoglobin of ≥2 g/dl, transfusion of ≥2 units of packed red blood cells, or fatal outcome.
56 secondary outcomes
Cerebrovascular events defined as Stroke
Time frame: 4 months
Cerebrovascular events defined as Stroke
Time frame: 8 months
Cerebrovascular events defined as Stroke
Time frame: 12 months
Cerebrovascular events defined as Stroke
Time frame: 16 months
Cerebrovascular events defined as Stroke
Time frame: 20 months
Cerebrovascular events defined as Stroke
Time frame: 24 months
Cerebrovascular events defined as Stroke
Time frame: 3 years
Cerebrovascular events defined as Stroke
Time frame: 4 years
Transient Ischemic Attacks (TIA)
Time frame: 4 months
Transient Ischemic Attacks (TIA)
Time frame: 8 months
Transient Ischemic Attacks (TIA)
Time frame: 12 months
Transient Ischemic Attacks (TIA)
Time frame: 16 months
Transient Ischemic Attacks (TIA)
Time frame: 20 months
Transient Ischemic Attacks (TIA)
Time frame: 24 months
Transient Ischemic Attacks (TIA)
Time frame: 3 years
Transient Ischemic Attacks (TIA)
Time frame: 4 years
Acute coronary syndromes
Time frame: 4 months
Acute coronary syndromes
Time frame: 8 months
Acute coronary syndromes
Time frame: 12 months
Acute coronary syndromes
Time frame: 16 months
Acute coronary syndromes
Time frame: 20 months
Acute coronary syndromes
Time frame: 24 months
Acute coronary syndromes
Time frame: 3 years
Acute coronary syndromes
Time frame: 4 years
Therapy persistence
Time frame: 4 months
Therapy persistence
Time frame: 8 months
Therapy persistence
Time frame: 12 months
Therapy persistence
Time frame: 16 months
Therapy persistence
Time frame: 20 months
Therapy persistence
Time frame: 24 months
Therapy persistence
Time frame: 3 years
Therapy persistence
Time frame: 4 years
Incidences of other clinical events
Time frame: 4 months
Incidences of other clinical events
Time frame: 8 months
Incidences of other clinical events
Time frame: 12 months
Incidences of other clinical events
Time frame: 16 months
Incidences of other clinical events
Time frame: 20 months
Incidences of other clinical events
Time frame: 24 months
Incidences of other clinical events
Time frame: 3 years
Incidences of other clinical events
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Background: PubMed 22172431Kakkar AK, Mueller I, Bassand JP, Fitzmaurice DA, Goldhaber SZ, Goto S, Haas S, Hacke W, Lip GY, Mantovani LG, Verheugt FW, Jamal W, Misselwitz F, Rushton-Smith S, Turpie AG. International longitudinal registry of patients with atrial fibrillation at risk of stroke: Global Anticoagulant Registry in the FIELD (GARFIELD). Am Heart J. 2012 Jan;163(1):13-19.e1. doi: 10.1016/j.ahj.2011.09.011. Epub 2011 Nov 20.
- Background: PubMed 23617744Apenteng PN, Murray ET, Holder R, Hobbs FD, Fitzmaurice DA; UK GARFIELD Investigators and GARFIELD Steering Committee. An international longitudinal registry of patients with atrial fibrillation at risk of stroke (GARFIELD): the UK protocol. BMC Cardiovasc Disord. 2013 Apr 23;13:31. doi: 10.1186/1471-2261-13-31.
- Background: PubMed 23108524Aalbers J. GARFIELD: a window on the real-life treatment of atrial fibrillation - South Africa joins the GARFIELD registry. Cardiovasc J Afr. 2012 Oct;23(9):528. No abstract available.
- Results publication: PubMed 23704912Kakkar AK, Mueller I, Bassand JP, Fitzmaurice DA, Goldhaber SZ, Goto S, Haas S, Hacke W, Lip GY, Mantovani LG, Turpie AG, van Eickels M, Misselwitz F, Rushton-Smith S, Kayani G, Wilkinson P, Verheugt FW; GARFIELD Registry Investigators. Risk profiles and antithrombotic treatment of patients newly diagnosed with atrial fibrillation at risk of stroke: perspectives from the international, observational, prospective GARFIELD registry. PLoS One. 2013 May 21;8(5):e63479. doi: 10.1371/journal.pone.0063479. Print 2013.
- Derived from this study: PubMed 39914996Cheng CY, Lian TY, Zhu XJ, Virdone S, Sun K, Camm J, Li XM, Goto S, Pieper K, Kayani G, Fang XH, Jing ZC, Kakkar AK; GARFIELD-AF Investigators. Atrial fibrillation outcomes in patients from Asia and non-Asia countries: insights from GARFIELD-AF. Open Heart. 2025 Feb 6;12(1):e003109. doi: 10.1136/openhrt-2024-003109.
- Derived from this study: PubMed 39832940Himmelreich JCL, Virdone S, Camm AJ, Pieper K, Harskamp RE, Verheugt FWA, Bassand JP, Misselwitz F, Pereira-Barretto AC, Cools F, Gibbs H, Kakkar AK; GARFIELD-AF investigators. Emulation of ARISTOTLE and ROCKET AF trials in real-world atrial fibrillation patients results in similar efficacy and safety as original landmark trials: insights from the GARFIELD-AF registry. Open Heart. 2025 Jan 19;12(1):e002966. doi: 10.1136/openhrt-2024-002966.
- Derived from this study: PubMed 39631531Camm CF, Virdone S, Jerjes-Sanchez C, Oh S, Eikelboom JW, Oto A, Fox KAA, Camm AJ, Pieper KS, Goto S, Ragy H, Kakkar AK; GARFIELD-AF registry. Association of care specialty with anticoagulant prescription and clinical outcomes in newly diagnosed atrial fibrillation: Results from the GARFIELD-AF registry. Int J Cardiol. 2025 Feb 15;421:132866. doi: 10.1016/j.ijcard.2024.132866. Epub 2024 Dec 2.
- Derived from this study: PubMed 37435777Bassand JP, Virdone S, Camm AJ, Fox KAA, Goldhaber SZ, Goto S, Haas S, Hacke W, Kayani G, Keltai M, Misselwitz F, Pieper KS, Turpie AGG, Verheugt FWA, Kakkar AK; GARFIELD-AF Investigators. Oral anticoagulation across diabetic subtypes in patients with newly diagnosed atrial fibrillation: A report from the GARFIELD-AF registry. Diabetes Obes Metab. 2023 Oct;25(10):3040-3053. doi: 10.1111/dom.15202. Epub 2023 Jul 12.
- Derived from this study: PubMed 37293139Camm AJ, Steffel J, Virdone S, Bassand JP, Fox KAA, Goldhaber SZ, Goto S, Haas S, Turpie AGG, Verheugt FWA, Misselwitz F, Herreros RC, Kayani G, Pieper KS, Kakkar AK; GARFIELD-AF Investigators. Guideline-directed medical therapies for comorbidities among patients with atrial fibrillation: results from GARFIELD-AF. Eur Heart J Open. 2023 May 19;3(3):oead051. doi: 10.1093/ehjopen/oead051. eCollection 2023 May.
- Derived from this study: PubMed 36825238Yuan L, Yang L, Zhang S, Xu Z, Qin J, Shi Y, Yu P, Wang Y, Bao Z, Xia Y, Sun J, He W, Chen T, Chen X, Hu C, Zhang Y, Dong C, Zhao P, Wang Y, Jiang N, Lv B, Xue Y, Jiao B, Gao H, Chai K, Li J, Wang H, Wang X, Guan X, Liu X, Zhao G, Zheng Z, Yan J, Yu H, Chen L, Ye Z, You H, Bao Y, Cheng X, Zhao P, Wang L, Zeng W, Tian Y, Chen M, You Y, Yuan G, Ruan H, Gao X, Xu J, Xu H, Du L, Zhang S, Fu H, Cheng X. Development of a tongue image-based machine learning tool for the diagnosis of gastric cancer: a prospective multicentre clinical cohort study. EClinicalMedicine. 2023 Feb 6;57:101834. doi: 10.1016/j.eclinm.2023.101834. eCollection 2023 Mar.
- Derived from this study: PubMed 36713019van Husen G, Virdone S, Pieper K, Kayani G, Fox KAA. Universal Clinician Device for improving risk prediction and management of patients with atrial fibrillation: an assumed benefit analysis. Eur Heart J Digit Health. 2022 Mar 25;3(2):181-194. doi: 10.1093/ehjdh/ztac011. eCollection 2022 Jun.
- Derived from this study: PubMed 34996784Fox KAA, Virdone S, Bassand JP, Camm AJ, Goto S, Goldhaber SZ, Haas S, Kayani G, Koretsune Y, Misselwitz F, Oh S, Piccini JP, Parkhomenko A, Sawhney JPS, Stepinska J, Turpie AGG, Verheugt FWA, Kakkar AK; GARFIELD-AF investigators*. Do baseline characteristics and treatments account for geographical disparities in the outcomes of patients with newly diagnosed atrial fibrillation? The prospective GARFIELD-AF registry. BMJ Open. 2022 Jan 7;12(1):e049933. doi: 10.1136/bmjopen-2021-049933.
- Sponsor's websiteLink provided by the sponsor.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ajay K Kakkar study director
Thrombosis Research Institute, London, UK
35 sites in 35 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Thrombosis Research Institute at 35 sites in 35 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Argentina, Australia, Austria, Belgium and 30 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: 4 months). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01090362, which also lists 43 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.